Label: UMCKA ALLERGY AND SINUS- pelargonium sidoides root, hydrastis canadensis whole, potassium chloride, sanguinaria canadensis root, pulsatilla vulgaris, silicon dioxide tablet, chewable

  • NDC Code(s): 53499-3194-2
  • Packager: Schwabe North American, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated November 18, 2019

If you are a consumer or patient please visit this version.

  • Active Ingredient Section

    Pelargonium sidoides 1X,

    Hydrastis canadensis 6X,

    Kali muriaticum 3X (Potassium chloride),

    Sanguinaria canadensis 6X,

    Pulsatilla 6X,

    Silicea 6X (Silicon Dioxide)

  • Inactive Ingredient Section

    sour Cherry Powder, 

    Citric Acid,

    Lactose monohydrate,

    Magnesium Sterate,

    Malic Acid,

    Maltodextrin,

    Mannitol,

    Natural Flavors,

    Croscarmellose Sodium,

    Sorbitol,

    Stearic acid,

    Xylitol

  • Purpose Section

    Shortens duration and reduces severity of symptoms associated with the common cold and throat, nasal, bronchial irritations and temporarily relieves allergy and sinus symptoms; cough, congestion, promotes sinus drainage, helps decongest sinus openings and passages, headache, sneezing/runny nose, burning, itchy eyes, sore throat, shrinks swollen nasal membranes, sinus presssure.

  • Indications and Usage Section

    Shortens duration and reduces severity of symptoms associated with the common cold and throat, nasal, bronchial irritations and temporarily relieves allergy and sinus symptoms; cough, congestion, promotes sinus drainage, helps decongest sinus openings and passages, headache, sneezing/runny nose, burning, itchy eyes, sore throat, shrinks swollen nasal membranes, sinus presssure.

  • Warnings Section

    Sore throat warning: severe or persistent sore throat for more than 2 days or if accompanied by high fever, headache, nausea, vomiting or rash maybe serious. 

    Consult a physician promptly.

    Ask a doctor before use if you have a persistant or chronic cough that lasts, is chronic such as ocurs with smoking, asthma, chronic bronchitis, or emphysema or is accompanied by excessive phlegm (mucus).

    Stop use and ask a doctor is new symptoms occur, symptoms worsen or do not get better within 7 days, fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persistent headache.

    These could be signs of a serious condition.

  • Ask a Doctor Section

    Ask a doctor before use if you have a persistant or chronic cough that lasts, is chronic such as ocurs with smoking, asthma, chronic bronchitis, or emphysema or is accompanied by excessive phlegm (mucus).

  • Stop Use Section

    Stop use and ask a doctor is new symptoms occur, symptoms worsen or do not get better within 7 days, fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persistent headache.

    These could be signs of a serious condition. 

  • Pregnancy or Breast Feeding Section

    If pregnant or breast-feeding, ask a healthcare professional before use. 

  • Keep Out of Reach of Children Section

    Keep out of reach of children. 

  • Dosage and Administration Section

    Chew or dissolve tablets in the mouth.

    Do not swallow whole.

    For best resutls, use at the first sign of symptoms and continue to use for an additional 48 hours after symptoms cease. 

    Adults and children 12 years of age and older: take 1 chewable tablet 3 times daily.

    Children 6-11 years of age: Take 1 chewable tablet 2 times daily.

    Children under 6 years of age: Consult a physician. 

  • 12194-Umcka Allergy and Sinus_A02

    12194 Umcka Allergy & Sinus_A02.jpg12194 Umcka Allergy & Sinus_A02.jpg

  • INGREDIENTS AND APPEARANCE
    UMCKA ALLERGY AND SINUS 
    pelargonium sidoides root, hydrastis canadensis whole, potassium chloride, sanguinaria canadensis root, pulsatilla vulgaris, silicon dioxide tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-3194
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E) PELARGONIUM SIDOIDES ROOT1 [hp_X]
    HYDRASTIS CANADENSIS WHOLE (UNII: R763EBH88T) (HYDRASTIS CANADENSIS WHOLE - UNII:R763EBH88T) HYDRASTIS CANADENSIS WHOLE6 [hp_X]
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE3 [hp_X]
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT6 [hp_X]
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS6 [hp_X]
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    CHERRY (UNII: BUC5I9595W)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALIC ACID (UNII: 817L1N4CKP)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MANNITOL (UNII: 3OWL53L36A)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SORBITOL (UNII: 506T60A25R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize16mm
    FlavorCHERRYImprint Code C
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-3194-22 in 1 CARTON06/01/2018
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/01/2018
    Labeler - Schwabe North American, Inc. (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe North America, Inc.831153908manufacture(53499-3194)